MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 026 SEPARATOR FLEX; NRY

Catalog Number PSF026

Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 026 separator flex (separator 026 flex) delivery wire was fractured approximately 42.0 cm from the proximal end, with slight bending of the wire just proximal and distal to the fracture.The segment distal to the fracture was kinked approximately 1.0 cm distal to the fracture.There was no visible damage to the separator bulb or atraumatic tip.Conclusions: evaluation of the returned device revealed the delivery wire was fractured and kinked.This damage may have occurred due to forceful handling of the separator 026 flex at extreme angles during advancement through a catheter.There was no visible damage to the separator bulb or atraumatic distal tip.The catheter 026 mentioned in the complaint was not returned for evaluation.Penumbra separators are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

While preparing a penumbra system 026 separator flex (separator 026 flex) on the back table for a thrombectomy procedure, the tip of the separator 026 flex broke off.It was reported that the separator 026 flex was being prepped through a penumbra system reperfusion catheter 026 (catheter 026) and that nothing out of the ordinary was noticed.The tip of the separator 026 flex broke prior to use and therefore, the separator 026 flex was not used in the procedure.The procedure was successfully completed using a new separator 026 flex and the same catheter 026.

• Brand Name: PENUMBRA SYSTEM 026 SEPARATOR FLEX
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7033963
• MDR Text Key: 93179014
• Report Number: 3005168196-2017-02035
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548010403
• UDI-Public: 00814548010403
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PSF026
• Device Lot Number: F65847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1